(64 days)
Not Found
No
The description focuses on mechanical and electrosurgical features, with no mention of AI or ML.
No.
This device is described as surgical instruments (scissors, graspers, and dissectors) used in laparoscopic procedures for tissue manipulation and coagulation, which are functional tools rather than therapeutic agents.
No
The device description indicates that the instruments are used for "transect, dissect, grasp, and coagulate tissue" during laparoscopic procedures, which are interventional actions. There is no mention of the device collecting, analyzing, or interpreting data for diagnostic purposes.
No
The device description clearly outlines physical components such as shafts, handles, blades, jaws, a rotator knob, and a Luer port, indicating it is a hardware-based surgical instrument.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "a variety of laparoscopic procedures to transect, dissect, grasp, and coagulate tissue." This describes a surgical instrument used on the body, not a device used to examine specimens from the body (like blood, urine, or tissue samples) to diagnose conditions.
- Device Description: The description details a surgical instrument with features like shafts, jaws, blades, ratcheting, rotation, and electrosurgical capability. These are characteristics of surgical tools, not diagnostic tests performed on samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
In summary, the DetachaTip® III Multi Use Instruments are surgical instruments used during laparoscopic procedures, not devices used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The DetachaTip® III Multi Use Instruments are intended for use in a variety of laparoscopic procedures to transect, dissect, grasp, and coagulate tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The DetachaTip® III Multi Use Laparoscopic Instrument family comprises a series of sterile, multi-use laparoscopic scissors, graspers and dissectors designed to be used in conjunction with an appropriately sized cannula. All the instruments provide monopolar electrosurgical capability via a standard 4mm monopolar post. A single handle design accommodates 33cm and 43cm instrument shafts. Instrument shafts are available in a variety of blade or jaw configurations.
For graspers and dissectors, a lever on the handle allows the user to activate the ratcheting feature in a fixed ON/OFF position or an intermittent position. The ratcheting mode changes from intermittent to "OFF" once the user releases the lever. The ratcheting feature is intended for use with the grasper and dissector shafts only. The design of the scissors instrument shaft does not allow for ratcheting of those instruments.
A rotator knob on the instrument shaft allows for 360°axial rotation of the shaft and tip. The devices are designed with a Luer port located on the rotator knob that allows for flushing of the central shaft prior to steam sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench and simulated use testing demonstrated the DetachaTip® III Multi Use Laparoscopic instruments are substantially equivalent to Detacha-Tip Surgical Instruments with regard to intended use, materials, technology, and performance. Design verification testing demonstrates the devices comply with the applicable sections of AAMI/ANSI ES60601-1:2005 and IEC 60601-2-2:2009. Material analysis demonstrates the DetachaTip III materials comply with the requirements of ISO 10993-1:2009.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K924283, K103508, K103282, K030890
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness
ConMed® DetachaTip® III Multi-Use Laparoscopic Instrument
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number K123260 as of December 14, 2012.
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502
Establishment Registration: 1320894
B. Company Contact
Lisa Anderson Manager, Regulatory Affairs T: (315) 624-3371 F: (315) 624-3225
C. Device Name
Proprietary Name: Common Name: Classification Name: Regulation Number: Product Code: Regulatory Class: Panel:
DetachaTip® III Multi Use Laparoscopic Instruments Electrosurgical, Cutting & Coagulation & Accessories 878.4400 GEI 11 General and Plastic Surgery
D. Predicate Devices
Device Name: Company Name:
510(k):
DetachaTip Surgical Instruments ConMed Corporation via acquisition of Imagyn Medical Technologies / Microsurge, Inc. K924283
Device Name: Company Name: 510(k):
Unimax Laparoscopic Instrument Unimax Medical Systems, Inc. K103508
1
.
Device Name: Company Name: 510(k):
Device Name: Company Name: 510(k): .
Laparoscopic Dissector Applied Medical Resources Corporation K103282
Laparoscopic Switch-Blade Scissors Snowden Pencer, Inc. K030890
E. Device Description
The DetachaTip® III Multi Use Laparoscopic Instrument family comprises a series of sterile, multi-use laparoscopic scissors, graspers and dissectors designed to be used in conjunction with an appropriately sized cannula. All the instruments provide monopolar electrosurgical capability via a standard 4mm monopolar post. A single handle design accommodates 33cm and 43cm instrument shafts. Instrument shafts are available in a variety of blade or jaw configurations.
For graspers and dissectors, a lever on the handle allows the user to activate the ratcheting feature in a fixed ON/OFF position or an intermittent position. The ratcheting mode changes from intermittent to "OFF" once the user releases the lever. The ratcheting feature is intended for use with the grasper and dissector shafts only. The design of the scissors instrument shaft does not allow for ratcheting of those instruments.
A rotator knob on the instrument shaft allows for 360°axial rotation of the shaft and tip. The devices are designed with a Luer port located on the rotator knob that allows for flushing of the central shaft prior to steam sterilization.
F. Intended Use / Indications for Use
The DetachaTip® III Multi Use Instruments are intended for use in a variety of laparoscopic procedures to transect, dissect, grasp, and coagulate tissue.
G. Non-clinical Performance Testing
Non-clinical bench and simulated use testing demonstrated the DetachaTip® III Multi Use Laparoscopic instruments are substantially equivalent to Detacha-Tip Surgical Instruments with regard to intended use, materials, technology, and performance. Design verification testing demonstrates the devices comply with the applicable sections of AAMI/ANSI ES60601-1:2005 and IEC 60601-2-2:2009. Material analysis demonstrates the DetachaTip III materials comply with the requirements of ISO 10993-1:2009.
H. Substantial Equivalence
The differences between the predicates and the modified design do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the ConMed DetachaTip® III Multi Use Laparoscopic instruments are safe and effective for their intended use and are substantially equivalent to the Detacha-Tip Surgical Instruments, the Unimax Laparoscopic Instruments, the Applied Medical Laparoscopic Dissector and the Snowden Pencer Switch-Blade Scissors.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Conmed Corporation % Ms. Lisa Anderson Manager. Regulatory Affairs 525 French Road Utica, New York 13502
December 21, 2012
Re: K123260
Trade/Device Name: ConMed Detacha Tip® III Multi-Use Laparoscopic Instruments Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI
Dated: October 17, 2012 Received: October 22, 2012
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device fabeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Lisa Anderson
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K123260
Device Name: ConMed DetachaTip®III Multi-Use Laparoscopic Instruments
Indications for Use:
The DetachaTip® III Multi Use Instruments are intended for use in a variety of laparoscopic procedures to transect, dissect, grasp, and coagulate tissue.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dwight Yen 2012.12.21 10:59:46 -05'00'
(Division Sign-Off)
Division of Surgical Devices
510(k) Number